Contacts of Health Care Companies With Guideline Coordinators

A Cross-Sectional Survey

Although medical guidelines are not legally binding (1) they have a major impact on the standards of medical care and doctors’ prescribing behaviors. A Cochrane review found indications that financial conflicts of interest might affect the wording of guideline recommendations (2). Accordingly, established guidance manuals for managing conflicts of interest in Germany already exist (www.awmf.org/regelwerk/downloads). Similarly, greater transparency regarding guideline funding is under discussion (3). The Cochrane review draws attention to the fact that influence can be wielded in other ways, beyond mere financial interests. For this reason we carried out an online survey of guideline coordinators to collect data regarding the question of whether and in what form contacts take place in the context of guideline development.

Methods

The study was conceived as an exploratory online survey. We wrote to all guideline coordinators of the valid S2e (a recommendation for health care that is based on a systematic analysis of scientific evidence), S2k (consensus based), and S3 (evidence- and consensus-based) guidelines listed in the register of the Association of the Scientific Medical Societies in Germany (AWMF) (register.awmf.org). We contacted guideline coordinators via publicly accessible email addresses and sent them a link to the online survey on 17 October 2023. We asked targeted/specific questions regarding contacts during the guideline’s development, the publication process (for example, receipt/sending of literature, invitations to advisory boards), and post-publication (demands for changes to the guidelines, if required with legal support). In free-text fields, participants were able to name further aspects and articulate their wishes to relevant stakeholders (for example, the medical scientific specialist societies or the AWMF) as regards the handling of contacts initiated by the healthcare industry. The questionnaire (4) was pre-tested on three participants. The survey was kept online until 21 November 2023 and one reminder was sent. The results were analyzed descriptively. The free-text comments were categorized by subject matter. The survey had been registered prospectively (DRKS-ID: DRKS00032687).

Results

We identified 618 persons in 794 guidelines and contacted them about the survey. The response rate was 38.2% (236/618). Most participants reported not having been contacted during the guideline development. 31 Participants reported having received literature, 29 reported telephone calls or visits, 52 had been invited to events or to participate in advisory boards (73 persons in total, 42 reported one, 26 reported two, and five reported all three options). Contacts took place in the context of subjects such as expensive or commonly prescribed medications, specific medical devices, and diagnostic methods (free-text comments). Altogether 15 participants reported legal disputes/discussions (Table). Contacts were perceived in different ways. 24 free-text responses included seven comments reporting explicit requests for certain products to be mentioned in the guidelines. In 41 free-text responses regarding advisory board invitations such a request was mentioned only once, 6 participants articulated explicitly that no attempt to influence the guideline had taken place (Box). Two free-text comments mentioned that patient organizations had contacted guideline authors.

Box

Perception of contacts

Table

Contacts in the context of guideline development

Free-text comments appealed to specialist societies and the AWMF to issue clear rulings, provide legal support, and make public statements. Furthermore, greater transparency was requested, for example the publication of incidents such as threats of lawsuits or legal procedures leading to changes to the guideline text in the guideline report or in registers. Participants appealed to politicians, for example, to provide more comprehensive public funding for guidelines (n=18).

Discussion

Guidelines of high methodological quality (S2/S3) are developed according to a standardized approach that includes a systematic literature search and/or a structured consensus process. The survey shows that approaches from the healthcare industry take place beyond/outside the methodological defaults, which participants perceived in different ways. A clear attempt to change guidelines in favor of healthcare businesses is the threat or implementation of legal steps with the aim of effecting changes to guideline contents or recommendations. Such an approach was described in individual cases.

Since medical scientific specialist societies—in contrast to the healthcare industry—often have limited financial resources, they may shy away from expensive litigation and hastily agree to a judicial arrangement. But such fears are mostly unfounded: in 2012, Cologne’s Higher Regional Court decided that guideline recommendations as a rule equate to expressed opinions, which fundamentally are subject to Article 5 Paragraph 1 of the Basic Law. Businesses accordingly have to accept critical comments. Exceptions to this rule are statements that are no longer objective or obviously false (5).

The present study recorded for the first time and initially in an exploratory fashion which contacts from healthcare businesses occurred in the context of guideline development and how these were experienced and perceived by those affected. The response rate is relatively high for an online survey, but the responses represent fewer than half the participants. This may also reflect that only a certain proportion of addressees consider the topic relevant. We can assume that the non-responders are primarily guideline coordinators without any experience of problematic incidents. This prompts us to assume that absolute numbers of problematic incidents are low. Still, the wish for support for the affected guideline groups—even if these are currently few in number—should be taken seriously.

Technical/professional support from the specialist societies and the AWMF in how to handle attempts at wielding influence as well as expanded public funding of guideline work could promote and ensure independent guideline development. More transparency may, for example, be reached by including possible legal procedures against guideline contents in the guideline report.

Sabine Gehrke-Beck, Karen Krüger, Felix Holzinger, Christoph Heintze, Hendrik Napierala

Ethics approval

The study was approved by the ethics committee at Charité-Universitätsmedizin Berlin ((EA4/115/23).

Conflict of interest statement

SGB is a member of the executive committee of DEGAM, the German College of General Practitioners and Family Physicians. CH, HN, FH, and KK are members of the section guidelines and quality promotion in DEGAM. HN is a member of the working group Planetary Health in the AWMF and in the past was active in Leitlinienwatch [guideline watch]. CN and HN are members of MEZIS reg. assoc.

Manuscript received on 14 May 2024, revised version accepted on 6 September 2024.

Translated from the original German by Birte Twisselmann, PhD.

Cite this as:
Gehrke-Beck S, Krüger K, Holzinger F, Heintze C, Napierala H: Contacts of health care companies with guideline coordinators—a cross-sectional survey. Dtsch Arztebl Int 2025; 122: 21–2. DOI: 10.3238/arztebl.m2024.0184

References

1. Nölling T: Es bleibt dabei: Leitlinien sind nicht rechtlich verbindlich. GMS Mitt AWMF 2014; 11: Doc6. DOI: 10.3205/awmf000295.

2. Nejstgaard CH, Bero L, Hróbjartsson A, et al.: Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations. Cochrane Database Syst Rev 2020; 12: MR000040

3. Napierala H, Schuster A, Gehrke-Beck S, Heintze C: Transparency of clinical practice guideline funding: a cross-sectional analysis of the German AWMF registry. BMC Med Ethics 2023; 24: 32

4. Gehrke-Beck S, Krüger K, Holzinger F, Heintze C, Napierala H: Supplementary material: approaches by the healthcare industry during guideline development: a cross-sectional survey of guideline coordinators (1_0). Zenodo 2024; DOI: 10.5281/zenodo.13373878.

5. OLG Köln: Urteil 15 U 221/11 28 O 523/11. www.onkopedia.com/de/news/urteil-olg-koeln (last accessed on 30 July 2024).